System for optimizing a drug dosage regimen over time

Abstract

A system for optimizing a patient's basal insulin dosage regimen over time, adapted to determine from blood glucose values whether and by how much to vary a patient's present recommended amount of the insulin-containing drug in order to maintain the patient's future blood glucose level measurements within a predefined range, and wherein a given blood glucose value is disregarded if no patient-actuated operation being indicative of the administration of a dose of an insulin containing drug has been detected in a pre-defined amount of time prior to the determination of the given blood glucose value.

The invention claimed is: 
     
       1. A system for optimizing a patient's basal insulin dosage regimen over time, comprising:
 detecting means that detect when a patient-actuated operation is performed, the operation being indicative of an administration of a dose of an insulin containing drug, 
 memory means adapted to store: 
 blood glucose data sets corresponding to a plurality of blood glucose values as a function of time, 
 data representing detected patient-actuated operations as a function of time, and 
 data representing an initial basal insulin dosage regimen, 
 a processor operatively connected to the memory means, the processor being programmed to determine, based on the blood glucose data sets, whether and by how much to vary a present recommended amount of insulin-containing drug in a present insulin dosage regimen in order to maintain blood-glucose-level measurements within a predefined range, and 
 output means that communicate to the patient with a recommendation in the patient's insulin dosage regimen, 
 wherein the processor is programmed to disregard a given blood glucose data set if no patient-actuated operation has been detected in a pre-defined amount of time prior to generating the given data set. 
 
     
     
       2. The system of  claim 1 , further comprising a drug delivery assembly, the drug delivery assembly comprising:
 a drug delivery device comprising:
 a reservoir for a drug, 
 an outlet for the drug, 
 a drug expelling mechanism for expelling the drug from the reservoir and out through the outlet, and 
 
 a cap device releasably mountable on the drug delivery device and adapted to cover the outlet in a mounted position, the cap device comprising: 
 the memory means and the processor, 
 the output means, and 
 the detecting means, 
 wherein the detecting means is adapted to detect a cap-off event when the cap device has been at least partially de-mounted from the drug delivery device for a pre-determined amount of time, the cap-off event being indicative of the administration of the dose of the insulin containing drug. 
 
     
     
       3. The system of  claim 1 , further comprising a drug delivery assembly, the drug delivery assembly comprising:
 a drug delivery device comprising:
 a reservoir for a drug, 
 an outlet for the drug, 
 a drug expelling mechanism configured to be set to expel a desired dose of the drug from the reservoir and out through the outlet when actuated, and 
 means that detect, store, and transmit dose data representing a size of an expelled dose, the expelling being indicative of the administration of the dose of the insulin containing drug, and 
 
 a cap device releasably mountable on the drug delivery device and adapted to cover the outlet in a mounted position, the cap device comprising: 
 the memory means and the processor, 
 the output means, and 
 the detecting means, 
 wherein the detecting means is adapted to receive dose data from the drug delivery device. 
 
     
     
       4. The system of  claim 1 , further comprising a drug delivery assembly, the drug delivery assembly comprising:
 a drug delivery device comprising:
 a reservoir for a drug, 
 an outlet for the drug, 
 a drug expelling mechanism for expelling the drug from the reservoir and out through the outlet, 
 the memory means and the processor, 
 the output means, and 
 the detecting means, 
 
 wherein the detecting means detect when the drug expelling mechanism has been actuated, the expelling being indicative of the administration of the dose of the insulin containing drug, and 
 a cap device releasably mountable on the drug delivery device and adapted to cover the outlet in a mounted position.